Health TrialsbyHealthPanel

Platelet-Rich Plasma for Partial Rotator Cuff Tears

ConditionsPartial Supraspinatus TearRotator Cuff Tears (RCTs)Rotator Cuff Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Nova de Lisboa

About this trial

The goal of this clinical trial is to learn whether platelet-rich plasma (PRP) injection, made from a participant's own blood, can help heal the tendon and improve shoulder symptoms in people with partial tears of the supraspinatus tendon.

The main questions it aims to answer are:

* Does PRP help the tendon heal? * Does PRP improve pain, shoulder movement, daily function, and shoulder magnetic resonance imaging (MRI) findings?

Researchers will compare PRP plus standard of care (physical therapy) to standard of care alone to see if PRP leads to better healing and better clinical results. Researchers will also study if differences in specific biomolecules in PRP are associated with differences in treatment response.

Participants will:

* receive standard of care treatment, with or without PRP injection depending on the study group * have blood collected for PRP preparation * have their pain, shoulder movement, and shoulder function assessed * undergo shoulder MRI scans * be followed over time to measure healing and symptom improvement

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eligible patients are at least 18 years old, and have clinical (VAS pain score ≥4, loss of >25% in ROM, positive in at least one clinical test such as Jobe, Neer, Drop arm, Hawins-Kennedy, Patte) and imaging findings compatible with partial supraspinatus tear, within 3 months of diagnosis.

Patients may have undergone conservative treatments, including lifestyle modification, oral analgesics, or physical therapy, with the exception of shoulder injections.

Must be willing to provide consent.

Disqualifiers

Patients less than 18 years old

Patients with other or concomitant rotator cuff or shoulder muscle/tendon tear(s), complete tears, SLAP tears ≥ grade 2

Patients with auto-immune based joint diseases, osteoarthritis (KL grade ≥ 2), adhesive capsulitis, infection, nerve-related conditions, immunocompromised conditions, malignancy, coagulopathy

Patients on antiplatelet, anticoagulant, antitumor or immunosuppressive drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Platelet-Rich Plasma (PRP) Injections

    Biological/Vaccine

    Autologous leucocyte-poor platelet-rich plasma prepared from peripheral blood collected on the day of treatment and administered as a single ultrasound-guided percutaneous injection at or near the partial supraspinatus tendon tear, in addition to standard rehabilitation care. PRP is processed by centrifugation and a residual sample is reserved for cellular and molecular characterization

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Standard Rehabilitation CareNo intervention 0 interventions
Group B: Platelet-Rich Plasma Injection Plus Standard Rehabilitation CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Target Shoulder Pain Intensity Measured by Visual Analog Scale (VAS)

Pain intensity in the target shoulder will be assessed using the Visual Analog Scale (VAS). The outcome measure is the change in VAS score from baseline to 24 months.

Time frame
At Diagnosis and 1, 3, 6, 12 and 24 month follow-ups

Secondary outcomes

1

Changes From Baseline in Constant-Murley Score and Subjective Shoulder Value

Shoulder function and clinical range of motion will be assessed using the Constant-Murley and Subjective Shoulder Value scores. The outcome measure is the change in score from baseline to 12 months.

Time frame
At Diagnosis and 1, 3, 6, 12 and 24 month follow-ups
2

Change From Baseline in 12-Item Short Form Survey (SF-12) Mental Health Score

Health-related quality of life will be assessed using the mental health domain of the 12-Item Short Form Survey (SF-12). The outcome measure is the change in score from baseline to 24 months.

Time frame
At Diagnosis and 3- and 12-month follow-ups
3

Change From Baseline in Supraspinatus Tear Size on Magnetic Resonance Imaging (MRI)

Structural tendon changes will be assessed by T2 mapping on MRI. The outcome measures are the change in supraspinatus tear size and the change in signal intensity from baseline to 12 months.

Time frame
At Diagnosis and 3- and 12-month follow-ups
4

Platelet-Rich plasma cell and molecular count

Platelet, leukocyte, growth factors, and cytokynes concentrations will be measured in the PRP sample prepared for injection

Time frame
Baseline, immediately after blood collection

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Nova de Lisboa

Lead sponsor

Hospital da Luz, Portugal

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: